Medicines zodak

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Zodak - instructions for use, reviews, analogs and release forms (10 mg tablets, syrup, oral drops) of a drug for the treatment of allergies, rhinitis and conjunctivitis in adults, children and pregnancy.

Table of contents:

Composition and interaction with alcohol

In this article you can read the instructions for using the drug Zodak. Reviews of site visitors - consumers of this medicine, as well as the opinions of specialist doctors on the use of Zodak in their practice are presented. We kindly ask you to actively add your reviews about the drug: whether the medicine helped or did not help get rid of the disease, what complications and side effects were observed, perhaps not stated by the manufacturer in the annotation. Analogues of Zodak in the presence of existing structural analogues. Use for the treatment of allergies, rhinitis and conjunctivitis in adults, children, as well as during pregnancy and lactation. Composition and interaction of the drug with alcohol.

Zodak is an antiallergic drug, a blocker of histamine H1 receptors. Cetirizine belongs to the group of competitive histamine antagonists. It has a pronounced antiallergic effect, prevents the development and facilitates the course of allergic reactions. Has antipruritic and antiexudative effect. Affects the early stage of allergic reactions, and also reduces the migration of inflammatory cells; inhibits the release of mediators involved in a late allergic reaction. Reduces capillary permeability, prevents the development of tissue edema, relieves spasm of smooth muscles. Eliminates skin reactions to the introduction of histamine, specific allergens, as well as to cooling (with cold urticaria).

It has virtually no anticholinergic and antiserotonin effects.

In therapeutic doses it has virtually no sedative effect. During the course of treatment, tolerance does not develop.

The effect of the drug begins after 20 minutes (in 50% of patients) or after 1 hour (in 95% of patients) and lasts for 24 hours.

Cetirizine dihydrochloride + excipients.

After oral administration, Zodak is quickly and almost completely absorbed from the gastrointestinal tract. Food intake does not have a significant effect on the amount of absorption, but in this case the rate of absorption is slightly reduced. Cetirizine does not penetrate into the cell. Does not penetrate the blood-brain barrier (BBB). Cetirizine is poorly metabolized in the liver to form an inactive metabolite. About 70% is excreted by the kidneys, mainly unchanged.

  • seasonal and year-round allergic rhinitis and conjunctivitis;
  • itchy allergic dermatoses;
  • hay fever (hay fever);
  • urticaria (including chronic idiopathic);
  • Quincke's edema.

Film-coated tablets 10 mg.

Drops for oral administration.

Instructions for use and dosage

The drug Zodak is used as prescribed by a doctor to avoid complications.

Inside, regardless of food intake.

Adults and children over 12 years of age

The drug Zodak is usually prescribed 1 film-coated tablet (10 mg cetirizine) 1 time per day.

Children aged 6 to 12 years

The drug Zodak is usually prescribed 1 film-coated tablet (10 mg cetirizine) once a day or 1/2 film-coated tablet 5 mg cetirizine) 2 times a day, morning and evening.

The drug is prescribed orally, regardless of food intake. Before taking, dissolve the drops in water.

Adults and children over 12 years old - 10 mg of cetirizine (20 drops or 2 scoops of syrup) once a day, daily, preferably in the evening.

Children from 6 to 12 years old - 10 mg of cetirizine (20 drops or 2 measuring spoons of syrup) once a day or 5 mg of cetirizine (10 drops or 1 measuring spoon) 2 times a day - morning and evening.

Children from 2 to 6 years old - 5 mg of cetirizine (10 drops or 1 measuring spoon of syrup) 1 time per day or 2.5 mg of cetirizine (5 drops or 1/2 measuring spoon of syrup) 2 times a day - morning and evening.

Children from 1 to 2 years old - 2.5 mg (5 drops) 2 times a day.

In case of renal failure, the recommended dose should be reduced by 2 times.

In case of liver dysfunction, the dose should be selected individually, reducing it to 5 mg per day or less, with special caution in case of simultaneous renal failure.

Elderly patients with normal renal function do not require dose adjustment.

Rules for using a bottle with a safety cap

The bottle is closed with a cap with a safety device that prevents children from opening it. The bottle opens by pressing the cap firmly down and then unscrewing it counterclockwise. After use, the bottle cap must be screwed on tightly again.

  • dry mouth;
  • dyspepsia;
  • headache;
  • drowsiness;
  • fatigue;
  • dizziness;
  • excitation;
  • migraine;
  • skin rash;
  • angioedema;
  • hives;
  • skin itching.
  • pregnancy;
  • lactation period;
  • children under 1 year of age (drops for oral administration);
  • children under 2 years of age (syrup);
  • hypersensitivity to the components of the drug.

Use during pregnancy and breastfeeding

The drug is contraindicated during pregnancy and lactation.

The simultaneous use of drugs that have a depressant effect on the central nervous system and alcohol consumption are not recommended.

Strengthens (mutually) deprivation and decrease in the speed of psychomotor reactions when consuming ethanol (alcohol); During treatment it is necessary to abstain from alcoholic beverages.

Drops for oral administration do not contain sugar (saccharin is used as a sweetener), so this dosage form can be prescribed to patients with diabetes.

10 ml of syrup (2 scoops) contains 3 g of sorbitol, which corresponds to 0.25 XE.

Impact on the ability to drive vehicles and operate machinery

During the treatment period, it is necessary to refrain from engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

No clinically significant interaction of Zodak with other drugs has been established.

Combined use with theophylline (400 mg per day) leads to a decrease in the overall clearance of cetirizine (the kinetics of theophylline does not change).

Analogues of the drug Zodak

Structural analogues of the active substance:

Source: http://instrukciya-otzyvy.ru/334-zodak-po-primeneniyu-analogi-tabletki-sirop-kapli-allergiya-rinit-konyunktivit.html

Zodak

· Therapy of itching and urticaria of various origins, including urticaria accompanied by fever (chronic idiopathic urticaria);

· symptomatic treatment of allergic seasonal rhinitis and year-round allergic rhinitis;

· symptomatic treatment of allergic conjunctivitis.

Zodak is a 2nd generation antiallergic drug with a prolonged effect. The active ingredient of the product is cetirizine dihydrochloride, a selective blocker of peripheral H1 receptors. Does not have significant antiserotonin and anticholinergic effects. When used in therapeutic doses, Zodak does not cause sedation, including drowsiness. The active substance of Zodak affects the histamine-dependent - early phase of allergic reactions, as well as the late cellular phase. Under the influence of cetirizine, the release of histamine from basophils and mast cells is inhibited, and the migration of eosinophils and other cells is reduced. When taking 5–60 mg of cetirizine, linear kinetics are observed. The total volume of distribution is 0.50 l/kg. The half-life of the active substance is 10 hours. The volume of absorption is not affected by food intake, however, the rate of absorption of cetirizine is reduced.

There was no accumulation effect when taking a dose of 10 mg every day for 10 days. The maximum concentration in the blood plasma after reaching the equilibrium concentration of ng/ml, which is achieved after 60±30 minutes. 93±0.3% of cetirizine is bound by blood proteins. It has no effect on the binding of warfarin to plasma proteins. It does not undergo active metabolic transformation during the initial passage through the liver. Approximately 2/3 of cetirizine is excreted unchanged in the urine. A study on volunteers revealed the absence of pharmacokinetic differences in both AUC and maximum concentration values. No differences in pharmacokinetic parameters were observed in adults of different racial backgrounds. The bioavailability of the active substance is the same for all dosage forms of the product: syrup, drops and tablets.

The tablet is taken with water, regardless of food. Do not chew! For adults and children over 12 years old – 10 mg/day (1 tablet) in 1 dose.

In pediatrics: children from 6 to 12 years old - 5 mg / day (1/2 tablet) 2 times / day, a single dose of 10 mg of Zodak is possible every day.

For adults and children over 12 years old – 10 mg (20 drops) 1 r/day. 1 ml of product contains 20 drops.

In pediatrics: from the first days of life to 2 years – 5 drops (2.5 mg) 2 times / day; from 2 to 6 years – 5 drops (2.5 mg of cetirizine) 2 times / day, 10 drops (5 mg) can be used

1 r/day; from 6 to 12 years - 10 drops (5 mg) 2 times / day, you can take 20 drops (10 mg) 1 time / day.

For adults and children over 12 years old – 10 mg (2 scoops) 1 r/day. 1 measuring spoon contains 5 ml of Zodak syrup. The spoon is equipped with divisions: ¼ - corresponds to 1.25 ml of syrup and ½ - 2.5 ml.

In pediatrics: from 1 to 2 years – 2.5 mg (half a measuring spoon) 2 times / day; from 2 to 6 years - 2.5 mg (half a measuring spoon) 2 times / day, you can take 5 mg (1 measuring spoon) 1 time / day; from 6 to 12 years – 5 mg (1 measuring spoon) 2 times / day, you can take 10 mg (2 measuring spoons) 1 time / day.

In the case of normally functioning kidneys, there is no need to reduce the dosage.

In case of moderate or severe impairment of renal function, it is necessary to establish individual intervals for taking Zodak, which depends on the severity of renal failure: for minor impairment (creatinine clearance - 50-79 ml/min) - there is no need for dose adjustment and changing the interval between doses; for mild disorders (creatinine clearance 30–49 ml/min) – 5 mg/day as usual; for severe disorders (creatinine clearance ≤ 30 ml/min) – 10 mg once a day after 2 days; in the terminal stage, if there are contraindications to hemodialysis (creatinine clearance ≤ 10 ml/min), the use of Zodak is contraindicated.

The dose of cetirizine for children with renal failure is calculated individually, based on body weight and creatinine clearance level.

There is no need to reduce the dosage.

Common to all dosage forms:

· a history of high susceptibility to hydroxyzine or cetirizine or to any other ingredients of Zodak;

· During pregnancy and breastfeeding;

· renal failure with creatinine clearance less than 10 ml/min.

For syrup – age up to 1 year.

Unlike antihistamine products of previous generations, which belong to the group of H1-receptor antagonists, the active substance of Zodak penetrates the blood-brain barrier in a small amount, so the development of a sedative effect is not expressed or expressed to a very mild degree. Although cetirizine acts selectively on peripheral H1 receptors, the anticholinergic effect is weak, but there have been reports of ocular accommodation disturbances, difficulty urinating, paradoxical stimulation of the central nervous system and a feeling of dry mouth.

From the hepatobiliary system: an increase in the content of bilirubin and the activity of liver enzymes (these side effects are transient and disappeared after discontinuation of the product).

Zodak is contraindicated during pregnancy in all trimesters. If Zodak is prescribed to a nursing mother, breastfeeding should be temporarily stopped.

If the recommended dose of Zodak is exceeded, symptoms develop, mainly associated with changes in the central nervous system, and anticholinergic effects of cetirizine are also likely. As a result of exceeding the dose by 5 times, the following symptoms of overdose have been reported: diarrhea, agitation, dizziness, nausea, fatigue, dilated pupils, headache, itching, sedation, nervousness, drowsiness, tachycardia, stupor, tremor and urinary retention.

No specific antidote has been identified. In case of overdose, supportive and symptomatic therapy is used. Immediately after taking a large dose, gastric lavage is recommended. Hemodialysis is not effective because cetirizine is mostly bound to blood proteins.

Studies of the pharmacokinetic parameters of the interaction of cetirizine with cimetidine, pseudoephedrine, ketoconazole, azithromycin and erythromycin did not reveal. There is a slight decrease in the clearance of cetirizine to 16% when combined with repeated doses of theophylline at a dosage of 400 mg/day. Moreover, with this combination, the excretion of theophylline does not change.

Zodak tablets – 10 mg, 5 doses; 10; thirty; 60; 90 pcs. in a blister pack. The tablets are white, oblong, biconvex, scored on one side.

Zodak drops for internal use – 10 mg in 1 ml, in 20 ml bottles. The drops are transparent, without color or with a slight yellow tint.

Zodak syrup – 5 mg/ml, 100 ml bottle. The syrup is transparent, without color or with a slight yellow tint. Has a characteristic banana smell.

At room temperature. Approved for over-the-counter release.

Active substance: cetirizine dihydrochloride.

Inactive ingredients: corn starch, lactose monohydrate, povidone, hydroxypropyl methylcellulose, titanium dioxide, talc, magnesium stearate, macrogol, dimethicone emulsion.

Active substance: cetirizine.

Inactive substances: propylparaben, methylparaben, glycerol 85%, sodium acetate, sodium saccharin, acetic acid, propylene glycol, purified water.

Active substance: cetirizine dihydrochloride.

Inactive ingredients: propylparaben, methylparaben, propylene glycol, glycerol 85%, sorbitol syrup, sodium acetate, sodium saccharin, banana flavor, acetic acid, purified water.

Tests have shown that Zodak has no clinically significant interaction with alcohol (in the case of a blood alcohol content of 0.5 g/l). However, it is not recommended to drink alcohol while taking Zodak. It is recommended to exercise caution for people whose activities involve increased demands for attention and quick reactions (drivers, machinists, machine maintenance, work at height, etc.). They also should not exceed the dose prescribed by the doctor.

Before using Zodak medication, you should consult your doctor.

The instructions are provided solely for familiarization with Zodak.

Group affiliation:

ALPHABETIC INDEX

Medprep.info is a leading reference book for medications and diseases with detailed instructions and photos.

This material is for educational purposes only and is not intended for medical advice, diagnosis or treatment.

Source: http://medprep.info/drug/medicament/762

Allergy treatment with Zodak

Zodak is a second generation drug designed to relieve allergies of various types. The active ingredient of the drug is cetirizine. This substance is included in antihistamines such as Cetrin, Zyrtec, etc.

Zodak effectively relieves spasms, swelling, itching and other allergic manifestations, having minimal impact on other receptors. This property allows the drug, when used, not to cause side effects (drowsiness, lethargy, etc.), which are observed with other antihistamines used in the treatment of allergies.

Therapeutic doses do not have antiserotonin, anticholinergic and sedative effects. Course treatment does not develop addiction. The drug begins to act 20 minutes after taking drops, tablets, syrup. The duration of action lasts for 24 hours.

Indications for use

The instructions for use of the medicinal product recommend using solutions, syrup, drops and tablets in the following cases:

  • development of allergic dermatosis, accompanied by severe itching;
  • the appearance of allergic conjunctivitis caused by exposure to an allergen;
  • seasonal or year-round symptoms of allergic rhinitis, accompanied by swelling of the nasal mucosa, runny nose, sneezing, rhinorrhea;
  • manifestations of acute and chronic urticaria, characterized by the appearance of a finely blistered rash resembling a nettle burn;
  • the drug is approved for use in cases of exacerbation of seasonal fevers that occur upon contact with pollen of flowering plants.

In addition, the medicine must be used in case of a sharp increase in symptoms, accompanied by angioedema and the development of anaphylactic shock. These symptoms require emergency medical treatment as they can be fatal.

Contraindications for use

Zodak should not be used if the following symptoms occur:

  • high susceptibility to the drug components;
  • the patient's pregnancy;
  • lactation period;
  • The drug should not be prescribed to a child under one year of age;
  • According to the annotation, drops, tablets, syrup and solution must be individually selected for people over 60 years of age. This is due to the possibility of reducing the filtration of nerve glomeruli.

In addition, the drug is prohibited for use in the development of a chronic process of severe renal failure. In this case, individual adjustment of Zodak dosage is necessary.

Instructions

For symptoms of the disease, Zodak can only be taken orally. The tablets must be swallowed without crushing, washed down with boiled water.

Drops are taken according to the instructions. Taking the medicine is not tied to food intake. The instructions recommend selecting the dose in accordance with the patient’s condition and the severity of symptoms.

Pills

One Zodak tablet contains 10 mg of cetirizine.

The instructions for use of the drug recommend the use of the following dosages:

  • Children from 6 to 12 years old – 5 mg (1/2 tablet), divided into 2 doses;
  • Patients over 12 years of age – 10 mg (1 tablet) once a day.

Drops

  • Patients over 12 years of age can be prescribed 10 mg (20 drops) 1 time per day;
  • Children from 1 to 2 years of age can take 5 drops 2 times a day;
  • Children from 2 years to 6 – 5 drops 2 times a day;
  • From 6 years to 12 – 10 drops 2 times a day.

Syrup

Currently, maximum convenience for children is observed when using syrup. One scoop is 5 mg. cetirizine. For kidney diseases, the dosage is selected individually.

  • Children from one year to 6 years old - it is recommended to use 2.5 mg (1/2 dosage spoon) 2 times a day;
  • From 6 to 12 years – 5 mg (1 dosage spoon) 2 times a day;
  • Zodak is prohibited for use by children under 1 year of age. The effect of the drug in the treatment of allergies in this age group can cause complications such as apnea with sudden cessation of respiratory activity and other side effects that threaten the child’s life.

Drops, syrups and tablets should be stored in a dark room. The temperature should not be higher than 20 degrees. The drug can be used for three years if all requirements are met.

The instructions for use of the antihistamine do not recommend combination with additional medications. Zodak is prescribed only by highly qualified specialists, because some medications can enhance negative manifestations.

Side effects

In most cases, Zodak is quite easily tolerated by patients. Occasionally, short-term negative manifestations may occur. These include:

  • from the central and peripheral system, Zodak tablets can cause migraine-like pain, fatigue, and dizziness. In rare cases, paradoxical stimulation is observed;
  • sometimes there is increased dryness of the mucous membranes, accompanied by thirst;
  • dyspepsia, attacks of nausea, vomiting, etc.;
  • a pinpoint hyperemic rash may appear on the skin, which causes severe itching;
  • in addition, symptoms of urticaria, angioedema, etc. appear.

In rare cases, the bilirubin level increases and difficulty urinating is observed. In addition, the enzyme activity of the liver increases. These symptoms usually disappear after stopping the medication.

Notes

The instructions for use indicate that Zodak drops and tablets should not be used in conjunction with medications that suppress the central nervous system.

In addition, you should not drink alcoholic beverages when prescribing a course of treatment.

Drops for internal use do not contain sugar. The sweetener is saccharin. This is an advantage for diabetics, due to the fact that these drops are approved for this category of patients. For comparison: two scoops of syrup (10 ml) contain only 3 grams of sorbitol, which corresponds to 0.25 XE.

When performing therapeutic measures to neutralize an acute attack of allergy with antihistamines, it is important to limit activities associated with increased concentration and rapid reaction.

Tablets should be prescribed with caution to patients suffering from kidney and liver diseases. In addition, an individual approach is required for people over 60 years of age.

The difference between Zodak and previous generations of antihistamines is manifested in the slight penetration of cetirizine through the blood-brain barrier. This property allows you to almost completely get rid of the sedative effect of the drug or tolerate it to a mild degree.

Overdose

May occur when taking 50 mg of the drug during the day. An overdose may be manifested by the following symptoms:

  • loss of orientation in space, possible delirium, incoherent speech;
  • the patient feels sleepy all the time and is lethargic (in rare cases, hyperexcitability and anxiety may occur);
  • there is constant aching pain, thirst;
  • There may be disruptions in cardiac activity, accompanied by arrhythmia;
  • very often Zodak can cause intestinal disorders (constipation or diarrhea).

If such manifestations occur, urgent treatment measures are necessary. They include emergency cleansing of the body from toxic substances that have entered the patient’s body. As a rule, tablets are prescribed (activated carbon, polysorb, etc.).

Analogs

The following drugs have a similar structure:

Reviews

Recently, many patients prefer to use Zodak to relieve allergies. Parents especially like this medicine because of its fairly convenient release form.

Children happily take sweet syrup, without additional persuasion. The bottle of medicine is equipped with a special cap that a child cannot open, which provides additional safety. Many children often take drops before vaccinations, as a preventive measure for patients predisposed to allergies.

In addition, the drops rarely cause drowsiness, unlike first-generation drugs. This allows you not to give up your usual lifestyle, spending most of your time at home. You can take the medicine 1 time per day. This allows you not to miss your next medication dose. Most patients really like Zodak due to its pharmacological action, ease of use, and relatively reasonable price.

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Source: http://allergiyanet.ru/lekarstva/zodak.html

Zodak

Instructions for use:

Prices in online pharmacies:

Zodak is an antiallergic drug.

Release form and composition

Zodak is produced in the following dosage forms:

  • Film-coated tablets: oblong, almost white or white, with a score line on one side (7 pieces in blisters, 1 blister in a cardboard box; 10 pieces in blisters, 1, 3, 6 , 9 or 10 blisters in a cardboard box);
  • Syrup: transparent, from light yellow to colorless (100 ml in dark glass bottles, 1 bottle in a cardboard box complete with a measuring spoon);
  • Drops for oral administration: from light yellow to colorless, transparent (20 ml in dark glass bottles with a dropper cap, 1 bottle in a cardboard box).

1 tablet contains:

  • Active substance: cetirizine – 10 mg (in the form of dihydrochloride);
  • Auxiliary components: lactose monohydrate, corn starch, povidone 30, magnesium stearate.

Shell composition: macrogol 6000, hypromellose 2910/5, talc, titanium dioxide, simethicone emulsion SE4.

The composition of 5 ml (1 measuring spoon) of syrup includes:

  • Active substance: cetirizine – 5 mg (in the form of dihydrochloride);
  • Auxiliary components: methyl parahydroxybenzoate, sodium saccharin dihydrate, propyl parahydroxybenzoate, propylene glycol, glycerol, glacial acetic acid, sorbitol, sodium acetate trihydrate, banana flavor, purified water.

The composition of 1 ml (20 drops) drops for oral administration includes:

  • Active substance: cetirizine – 10 mg (in the form of dihydrochloride);
  • Auxiliary components: methyl parahydroxybenzoate, glacial acetic acid, propyl parahydroxybenzoate, glycerol, propylene glycol, sodium acetate trihydrate, sodium saccharinate dihydrate, purified water.

Indications for use

  • Conjunctivitis and allergic rhinitis (year-round and seasonal);
  • Hay fever (hay fever);
  • Itchy allergic dermatoses;
  • Quincke's edema;
  • Urticaria (including idiopathic).

Contraindications

  • Pregnancy and lactation;
  • Hypersensitivity to the components of the drug.

Depending on the form of release, Zodak is prescribed to children: tablets - from 6 years; syrup – from 2 years; drops for oral administration – from 1 year.

Zodak should be taken with caution in elderly patients (due to a possible decrease in glomerular filtration) and patients with severe and moderate chronic renal failure (the dosage regimen must be adjusted).

Directions for use and dosage

Zodak is taken orally, regardless of food intake. To avoid complications, the drug should be used only as prescribed by a doctor.

The tablets should be swallowed whole and washed down with a small amount of water. Drops must be dissolved in water before use.

The drug dosage regimen is determined by age:

  • Adults and children over 12 years of age: 10 mg (1 tablet, 2 measuring spoons of syrup or 20 drops) 1 time per day;
  • Children 6-12 years old: 10 mg (1 tablet, 2 measuring spoons of syrup or 20 drops) 1 time per day or 5 mg (1/2 tablet, 1 measuring spoon of syrup or 10 drops) 2 times a day (in the morning or evening time);
  • Children 2-6 years old: 5 mg (1 measuring spoon of syrup or 10 drops) 1 time per day or 2.5 mg (1/2 measuring spoon of syrup or 5 drops) 2 times a day (in the morning or evening) ;
  • Children 1-2 years old: 2.5 mg (5 drops) 2 times a day (in the morning or evening).

The dose of Zodak in the form of tablets for elderly patients and patients with severe functional disorders of the kidneys and/or liver is prescribed individually, in a reduced dose.

The daily dose of syrup and drops for oral administration in patients with renal failure should be reduced by 2 times. For functional liver disorders, the dose is selected individually (as a rule, it is reduced by 2 times; special caution is required in case of simultaneous renal failure). In elderly patients with normal renal function, no dosage adjustment is required.

If a dose of Zodak is accidentally missed, the next dose should be taken as soon as possible. In cases where the time for the next dose of the drug is approaching, the dose (without increasing) should be taken according to the schedule.

Side effects

As a rule, Zodak is well tolerated. Side effects develop rarely and are transient.

The following disorders may occur during use of the drug:

  • Central nervous system: dizziness, headache, fatigue, drowsiness, migraine, agitation;
  • Digestive system: dyspepsia, dry mouth;
  • Allergic reactions: angioedema, skin rash or itching, urticaria.

special instructions

The daily dose of syrup (10 ml) contains 3000 mg of sorbitol, which corresponds to 0.25 XE (bread unit). The drops do not contain sugar, so Zodak in this dosage form can be taken by patients with diabetes.

It is not recommended to take Zodak simultaneously with drugs that depress the central nervous system, as well as with alcohol.

During the period of therapy, it is recommended to refrain from performing potentially dangerous types of work that require high concentration and rapid psychomotor reactions.

Drug interactions

Clinically significant interactions of Zodak with other drugs have not been established.

When used simultaneously with theophylline (at a dose of 400 mg per day), the overall clearance of cetirizine is reduced (the kinetics of theophylline remains unchanged).

Analogs

Analogues of Zodak are: Zirtec, Zincet, Zetrinal, Parlazin, Cetrin, Cetirizine, Cetirizine DS, Cetirizine Hexal, Allertek, Letizen, Alerza.

Terms and conditions of storage

Zodak in tablet form should be stored in a dry place, out of reach of children, at a temperature of °C. Syrup and drops for oral administration do not require special storage conditions.

Shelf life – 3 years.

Conditions for dispensing from pharmacies

Available without a prescription.

Zodak tablets 10 mg 10 pcs.

Zodak tab. p.p.o. 10mg n10

Zodak 10 mg n10 tablet

Zodak 10mg No. 10 tablets

Zodak drops 10 mg/ml 20 ml

Zodak drops internal 10mg/ml 20ml n1

Zodak 10mg/ml drops for oral administration 20ml dropper bottle

Information about the drug is generalized, provided for informational purposes and does not replace official instructions. Self-medication is dangerous to health!

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Zodak

Description current as of 10/24/2015

  • Latin name: Zodac
  • ATX code: R06AE07
  • Active ingredient: Cetirizine
  • Manufacturer: Zentiva ks (Czech Republic)

Compound

Zodak tablets contain the active ingredient cetirizine dihydrochloride, as well as additional components: corn starch, lactose monohydrate, magnesium stearate, povidone 30. The tablet shell consists of macrogol 6000, hypromellose 2910/5, talc, titanium dioxide, simethicone SE4 emulsion.

The composition of the product in the form of syrup includes the active component cetirizine dihydrochloride, as well as additional substances - propyl parahydroxybenzoate, propylene glycol, methyl parahydroxybenzoate, sorbitol, glycerol, sodium acetate trihydrate, sodium saccharin dihydrate, flavoring, glacial acetic acid, water.

The drug in the form of drops contains the active component cetirizine dihydrochloride and additional substances: propyl parahydroxybenzoate, methyl parahydroxybenzoate, propylene glycol, glycerol, sodium acetate trihydrate, sodium saccharinate dihydrate, glacial acetic acid, water.

Release form

The medicine is available in tablets, as well as in the form of syrup and drops.

Zodak tablets are white or almost white in color, oblong in shape, with a score on one side of the tablet. They are contained in blisters of 7 or 10 pieces. Blisters are placed in cardboard packs.

Zodak syrup is transparent, it can be completely colorless or have a light yellow tint. Packaged in 100 ml dark glass bottles. A bottle and a measuring spoon are placed in a cardboard box.

Zodak drops are transparent; they can be completely colorless or have a light yellow tint. Contained in 20 ml dark glass bottles, in addition to the bottle, a dropper cap is placed in a cardboard box.

pharmachologic effect

This medicine is a second generation antiallergic drug that has a prolonged effect. The summary of the drug indicates that the active component cetirizine is part of the group of competitive histamine antagonists. The substance blocks H1-histamine receptors, but has almost no antiserotonin and anticholinergic effect. It has a pronounced antiallergic effect, while acting as an antiexudative and antipruritic agent.

Already at an early stage of allergic reactions it reduces their severity. Reduces the degree of migration of inflammatory cells. It has a depressing effect on the release of mediators that take part in a late allergic reaction.

Cetirizine also relieves spasm of smooth muscles and reduces capillary permeability, which helps prevent tissue edema. Provides a reduction in skin reaction to the introduction of specific allergens, histamine, and hypothermia (in case of cold urticaria).

The use of the drug in a therapeutic dosage does not lead to a sedative effect on the body and does not cause drowsiness.

Pharmacokinetics and pharmacodynamics

After tablets, drops or syrup have been taken orally, rapid absorption of the active substance from the gastrointestinal tract is noted. The highest concentration of the active component is observed minutes after taking the medicine.

Eating does not have a significant effect on the degree of absorption, but if the drug was taken during a meal, the rate of its absorption decreases slightly.

The product binds to blood proteins by approximately 93%. It does not penetrate the blood-brain barrier and does not enter cells.

If Zodak is taken for 10 days at a dose of 10 mg, the drug does not accumulate in the body.

The main part is excreted unchanged by the kidneys. After the drug has been taken once, the half-life is approximately 10 hours. When taking the medicine by children from 2 to 12 years old, the half-life is reduced to 5-6 hours.

If the patient has impaired renal function or is on hemodialysis, the half-life becomes three times longer, and clearance is also reduced by 70%.

Indications for use

The medicine Zodak in various forms of release is prescribed for the following conditions and diseases:

Contraindications

Some contraindications to the use of Zodak are also identified:

  • child's age up to 6 years (when taking drops and syrup - for children under 1 and 2 years old, respectively);
  • pregnancy and breastfeeding;
  • severe sensitivity to the components of the product.

Zodak should be prescribed with caution to people with chronic renal failure, as well as elderly patients.

Side effects

As a rule, the drug is well tolerated. But sometimes in the process of taking the drug, some side effects may appear, for which Zodak tablets, as well as other forms of the drug, should be taken with caution.

The following side effects are possible:

Instructions for use of Zodak (Method and dosage)

Zodak medicine should be used only after a doctor’s prescription to prevent complications. The drug is intended for oral administration, and food intake does not matter.

Zodak tablets, instructions for use

The tablets are swallowed whole, washed down with water. Children over 12 years of age and adults receive 1 tablet. 1 per day. Children aged 6 to 12 years receive 1 tablet per day or half a tablet in the morning and evening. It is important that the dosage of the drug for elderly patients is prescribed by a doctor. The dosage of tablets is also determined individually for patients with impaired renal function.

Zodak syrup, instructions for use

Adult patients and children over 12 years of age receive 2 scoops of the drug once a day. Patients aged 6 to 12 years receive 2 scoops of the drug once a day or 1 scoop in the morning and evening. Patients from 2 to 6 years old should receive 1 measuring spoon once a day or half a spoon in the morning and evening. For people with renal failure, the dose should be halved. Elderly people with normal kidney function may not need dose adjustments.

When using the drug, you should adhere to the rules for using the safety cap. If other drugs (tablets, ointments, etc.) are used in parallel, you should first consult a doctor.

Zodak drops, instructions for use

Drops are used internally; before taking them internally, you need to dissolve the drops in liquid. Adults and children over 12 years of age should take 20 drops of Zodak once a day. It is recommended to take the product in the evening. Children aged 6 to 12 years should take 20 drops of the drug once a day or 10 drops of the drug in the morning and in the evening. Children from 1 to 2 years old receive 5 drops twice a day. For people with kidney failure, the dosage of Zodak drops is halved. The annotation for the drops indicates that in old age, patients with healthy kidneys receive the usual dose. Please note that the medicine bottle is closed with a safety cap.

Overdose

In case of an overdose of the drug, the following negative manifestations may occur: a feeling of lethargy and drowsiness, headaches, fatigue and weakness, tachycardia. Irritability may develop, urinary retention, constipation, and dry mouth are also noted.

In case of overdose, symptomatic treatment is indicated. There is no specific antidote. Gastric lavage is used, and activated carbon tablets are indicated.

Interaction

If, while taking Zodak for allergies, the patient takes any other medications for allergies and other diseases, it is important to consider the possibility of interaction.

With the simultaneous use of cetirizine and Theophylline (400 mg/day), there is a decrease in the total clearance of cetirizine, but there is no change in the kinetics of theophylline.

In the process of studying the pharmacokinetic parameters of the process of interaction of cetirizine with Ketoconazole, Pseudoephedrine, Cimetidine, Erythromycin, Azithromycin, no changes were found. When combined with macrolides or Ketoconazole, no changes in the electrocardiographic profile (clinically significant) were detected.

Cetirizine does not affect the ability of Warfarin to bind to blood proteins. With this combination, the volume of absorption does not change, but the rate of absorption decreases.

Terms of sale

You can buy Zodak without a doctor's prescription.

Storage conditions

All forms of the medicine should be stored out of the reach of children, at a temperature of 10-25°C, and protected from moisture.

Best before date

special instructions

Caution should be exercised when taking Zodak to elderly people, as well as to patients who have impaired liver and kidney function. It is important that a specialist prescribe the drug to elderly patients individually.

You should not take alcohol during treatment, as well as medications that have a depressing effect on the central nervous system.

It is advisable not to drive vehicles or operate dangerous machinery during treatment with the drug.

Since the drops do not contain sugar, they can be prescribed to people who have diabetes.

Analogues of Zodak

Zodak for children

Reviews indicate that drops for children are often used to treat allergies. The drug effectively copes with severe allergy symptoms. It is important that the dosage is carried out as indicated in the instructions for the drops for children. It is important to consider not only how to take Zodak for children, but also at what age a child is contraindicated in this or that form of this remedy. Thus, tablets can be used for patients after 6 years of age, syrup for children over 2 years of age, drops for patients over 1 year of age.

Zodak during pregnancy and lactation

The drug is contraindicated during pregnancy, as well as throughout the entire period of breastfeeding.

Reviews about Zodak

Most reviews online about this product are positive. It is noted that the medicine is relatively inexpensive, but it quickly helps to reduce the negative symptoms associated with allergies. Positive reviews of Zodak drops are often left by parents who have used this remedy for children. The drops are convenient to take, and there are no negative effects when taken. Reviews of Zodak tablets are often written by those who have suffered from allergies for many years, noting that with the help of these tablets it was possible to significantly improve their condition during periods of manifestation of the disease.

Zodak price, where to buy

The cost depends on the form of release and place of sale. The average price of Zodak in 10 mg tablets (10 pcs.) is rubles. Allergy tablets can be purchased without a prescription. How much the drug costs in tablets depends on the packaging. The price of Zodak in drops is rubles per 20 ml package. The price of 100 ml syrup is on average 180 rubles per package.

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BIOSPHERE

Education: Graduated from Rivne State Basic Medical College with a degree in Pharmacy. Graduated from Vinnitsa State Medical University named after. M.I. Pirogov and internship at his base.

Work experience: From 2003 to 2013 – worked as a pharmacist and manager of a pharmacy kiosk. She was awarded diplomas and decorations for many years of conscientious work. Articles on medical topics were published in local publications (newspapers) and on various Internet portals.

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The site administration and the authors of the articles are not responsible for any losses and consequences that may arise when using the site materials.

Source: http://medside.ru/zodak

ZODAK

◊ Film-coated tablets, white or almost white, oblong, with a score line on one side.

Excipients: lactose monohydrate - 73.4 mg, corn starch - 33 mg, povidone 4 mg, magnesium stearate - 1.2 mg.

Shell composition: hypromellose 2910/5 - 3.45 mg, macrogol.35 mg, talc - 0.35 mg, titanium dioxide - 0.80 mg, simethicone SE4 emulsion - 0.05 mg.

7 pcs. - blisters (1) - cardboard packs.

10 pieces. - blisters (1) - cardboard packs.

10 pieces. - blisters (3) - cardboard packs.

10 pieces. - blisters (6) - cardboard packs.

10 pieces. - blisters (9) - cardboard packs.

10 pieces. - blisters (10) - cardboard packs.

◊ Drops for oral administration are transparent, colorless to light yellow.

Excipients: methyl parahydroxybenzoate, propyl parahydroxybenzoate, glycerol, propylene glycol, sodium saccharin dihydrate, sodium acetate trihydrate, glacial acetic acid, purified water.

20 ml - dark glass bottles (1) with a dropper stopper - cardboard packs.

Cetirizine is a metabolite of hydroxyzine, belongs to the group of competitive histamine antagonists, blocks histamine H1 receptors , and has virtually no anticholinergic and antiserotonin effects.

It has a pronounced antiallergic effect, prevents the development and facilitates the course of allergic reactions: at a dose of 10 mg 1 or 2 times a day, it inhibits the late phase of eosinophil aggregation in the skin and conjunctiva of patients prone to atopy. Has antipruritic and antiexudative effect. Affects the early stage of allergic reactions, and also reduces the migration of inflammatory cells; inhibits the release of mediators involved in a late allergic reaction. Reduces capillary permeability, prevents the development of tissue edema, relieves spasm of smooth muscles. Eliminates skin reactions to the introduction of histamine, specific allergens, as well as to cooling (with cold urticaria).

In therapeutic doses it has virtually no sedative effect. During the course of treatment, tolerance does not develop.

The effect of the drug begins after 20 minutes in 50% of patients, after 1 hour in 95% of patients and persists for 24 hours.

Clinical efficacy and safety

Studies in healthy volunteers have shown that cetirizine at doses of 5 or 10 mg significantly inhibits the rash and erythema response to high concentrations of histamine in the skin, but the correlation with efficacy has not been established. In a 6-week placebo-controlled study involving 186 patients with allergic rhinitis and concomitant mild to moderate bronchial asthma, it was shown that taking cetirizine at a dose of 10 mg 1 time / day reduced the symptoms of rhinitis and did not affect pulmonary function.

The results of this study confirm the safety of cetirizine in patients suffering from allergies and mild to moderate bronchial asthma.

A placebo-controlled study showed that taking cetirizine at a dose of 60 mg/day for 7 days did not cause a clinically significant prolongation of the QT interval.

Taking cetirizine at the recommended dose showed an improvement in the quality of life of patients with year-round and seasonal allergic rhinitis.

In a 35-day study in patients aged 5-12 years, there was no evidence of resistance to the antihistamine effect of cetirizine. The normal skin reaction to histamine was restored within 3 days after discontinuation of the drug with repeated use.

A 7-day placebo-controlled study of cetirizine in syrup dosage form involving 42 patients aged 6 to 11 months demonstrated the safety of the drug. Cetirizine was prescribed at a dose of 0.25 mg/kg 2 times/day, which approximately corresponded to 4.5 mg/day (dose range was from 3.4 to 6.2 mg/day).

Use in children aged 6 to 12 months is possible only as prescribed by a doctor and under strict medical supervision.

The pharmacokinetic parameters of cetirizine when used in doses from 5 to 60 mg change linearly.

After oral administration, cetirizine is quickly and well absorbed from the gastrointestinal tract. Cmax is reached in about a minute and is 300 ng/ml. Various pharmacokinetic parameters, such as C max and AUC, are homogeneous. Food intake does not have a significant effect on the amount of absorption, but in this case the rate of absorption is slightly reduced.

The bioavailability of various dosage forms of cetirizine (solution, capsules, tablets) is comparable.

Plasma protein binding is approximately 93±0.3%. The V d is low (0.5 l/kg), the drug does not penetrate into the cell. The drug does not penetrate the BBB. Excreted in breast milk.

Cetirizine is poorly metabolized in the liver to form an inactive metabolite. When used at a dose of 10 mg for 10 days, no accumulation of the drug is observed.

After a single dose, T1 /2 is about 10 hours. 70% of the dose is excreted by the kidneys, mainly unchanged. The systemic clearance is about 54 ml/min.

Pharmacokinetics in special clinical situations

In children aged 6 to 12 years, T1 /2 is 6 hours, at the age of 2 to 6 years - 5 hours, at the age of 6 months to 2 years it is reduced to 3.1 hours.

In 16 elderly patients, with a single dose of 10 mg, T1 /2 was 50% higher and clearance was 40% lower compared to younger patients. The decreased clearance of cetirizine in elderly patients is likely due to decreased renal function in this category of patients.

In patients with mild renal failure (creatinine clearance >40 ml/min), pharmacokinetic parameters are similar to those in healthy volunteers with normal renal function. In patients with moderate renal failure (creatinine clearance <7 ml/min) and in patients on hemodialysis (creatinine clearance <7 ml/min), when taking the drug orally at a dose of 10 mg, T1 /2 is extended by 3 times, and the total clearance decreases by 70% relative to healthy volunteers with normal kidney function. For patients with moderate or severe renal impairment, appropriate changes in the dosage regimen are required. Cetirizine is poorly removed from the body during hemodialysis.

In patients with chronic liver diseases (hepatocellular, cholestatic and biliary cirrhosis), with a single dose of 10 or 20 mg, T1 /2 increases by approximately 50%, and clearance decreases by 40% compared to healthy volunteers. Dose adjustment is only necessary if the patient with hepatic insufficiency also has concomitant renal insufficiency.

— seasonal and year-round allergic rhinitis and conjunctivitis;

- itchy allergic dermatoses;

- hay fever (hay fever);

- urticaria (including chronic idiopathic);

For adults and children 6 months and older, for relief:

- nasal and ocular symptoms of year-round (persistent) and seasonal (intermittent) allergic rhinitis and allergic conjunctivitis (itching, sneezing, nasal congestion, rhinorrhea, lacrimation, conjunctival hyperemia);

- symptoms of chronic idiopathic urticaria.

— end-stage renal failure (creatinine clearance <10 ml/min);

- hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome;

- children under 6 years of age;

- hypersensitivity to the components of the drug.

with caution in case of chronic renal failure of moderate and severe severity (adjustment of the dosage regimen is required); chronic liver diseases (hepatocellular, cholestatic or biliary cirrhosis of the liver) (dose adjustment is required only with a concomitant decrease in GFR); elderly patients (possibly decreased glomerular filtration rate).

— end-stage renal failure (creatinine clearance <10 ml/min);

- children under 6 months of age (due to limited data on effectiveness and safety);

- hypersensitivity to cetirizine, hydroxyzine or piperazine derivatives, as well as other components of the drug.

with caution in case of chronic renal failure (creatinine clearance >10 ml/min, dosage adjustment required); epilepsy and increased convulsive readiness; patients with predisposing factors to urinary retention (spinal cord lesions, prostatic hyperplasia); elderly patients (with an age-related decrease in GFR); children under 1 year of age; during breastfeeding.

Before using Zodak, you should consult your doctor to avoid complications.

The drug is taken orally, regardless of food intake.

The tablets should be swallowed whole with a small amount of water.

Adults and children over 12 years of age are prescribed 1 tablet. (10 mg cytirizine) 1 time/day.

Children aged 6 to 12 years Zodak are prescribed, as a rule, 1 tablet. (10 mg of itirizine) 1 time/day or 1/2 tablet. (5 mg cytirizine) 2 times a day, morning and evening.

In patients with renal failure, the dose of the drug should be reduced depending on the CC: for CCml/min - 5 mg 1 time/day; priml/min - 5 mg every other day.

When prescribing the drug to elderly patients with renal failure, the dose should be adjusted depending on the value of CC.

CC for men can be calculated based on serum creatinine concentration using the following formula:

CC for women can be calculated by multiplying the resulting value by a coefficient of 0.85.

Patients with impaired liver function alone do not require dosage adjustment.

If you accidentally miss the time of taking the drug, the next dose should be taken at the first opportunity. If the time for the next dose of the drug is approaching, the next dose should be taken as scheduled, without increasing the total dose.

Before taking the drops, drop them into a spoon or dissolve them in water. The amount of water to dissolve the drug should correspond to the amount of liquid that the patient (especially a child) is able to swallow. The solution should be taken immediately after preparation.

Adults and children over 12 years of age are prescribed 10 mg of cetirizine (20 drops) 1 time/day.

Sometimes an initial dose of 5 mg (10 drops) may be sufficient if satisfactory control of symptoms is achieved.

In elderly patients with normal renal function, there is no need to reduce the dose.

When prescribing the drug to patients with impaired renal function in cases where alternative treatment cannot be prescribed, the dose should be adjusted depending on the value of CC, since cetirizine is excreted from the body mainly by the kidneys.

The CK indicator for men can be calculated based on the concentration of serum creatinine in the blood plasma using the following formula:

CC for women can be calculated by multiplying the resulting value by a coefficient of 0.85.

For adult patients with impaired renal function, dosing is carried out according to the table below.

In patients with impaired liver function, dosage regimen adjustment is not required. In patients with impairment of both liver and kidney function, dosage adjustment is recommended (see table above).

Children aged 6 to 12 years are prescribed 5 mg (10 drops) 2 times a day; children aged 1 to 6 years - 2.5 mg (5 drops) 2 times a day; children aged 6 to 12 months - 2.5 mg (5 drops) 1 time / day.

Use in children from 6 to 12 months is possible only as prescribed by a doctor and under strict medical supervision.

For children with renal failure, the dose is adjusted taking into account CC and body weight.

Instructions for opening a bottle with a safety cap

The bottle is closed with a cap with a safety device that prevents children from opening it. The bottle opens by pressing the cap firmly down and then unscrewing it counterclockwise. After use, the bottle cap must be screwed on tightly again.

Data obtained from clinical studies

The results of clinical studies have demonstrated that the use of cetirizine in recommended doses leads to the development of minor adverse effects from the central nervous system, including drowsiness, fatigue, dizziness and headache. In some cases, paradoxical stimulation of the central nervous system has been reported.

Despite the fact that cetirizine is a selective blocker of peripheral H1 receptors and has virtually no anticholinergic effect, isolated cases of difficulty urinating, disturbances of accommodation and dry mouth have been reported.

Liver dysfunction has been reported, accompanied by increased activity of liver enzymes and bilirubin. In most cases, adverse events resolved after discontinuation of cetirizine dihydrochloride.

List of unwanted side reactions

Data are available from double-blind, controlled clinical trials comparing cetirizine with placebo or other antihistamines given at recommended doses (10 mg once daily for cetirizine) in more than 3,200 patients on which a reliable analysis can be made safety data.

According to the results of the pooled analysis, in placebo-controlled studies with the use of cetirizine at a dose of 10 mg, the following adverse reactions were identified with a frequency of 1% or higher:

Although the incidence of somnolence in the cetirizine group was higher than that in the placebo group, most cases were mild or moderate in severity. When objectively assessed in other studies, it was confirmed that the use of cetirizine at the recommended daily dose in healthy young volunteers does not affect their daily activities.

In placebo-controlled studies in children aged 6 months to 12 years, the following adverse reactions were identified with an incidence of 1% or higher:

Post-registration experience

In addition to the adverse events identified during clinical trials and described above, the following adverse reactions were observed during post-registration use of the drug.

Based on data from post-marketing use of the drug, adverse events are divided into MedDRA organ system classes and incidence.

The incidence of adverse events was determined as follows: very often (>1/10), often (>1/100, <1/10), infrequently (>1/1000, <1/100), rarely (>1/10,000 , <1/1000), very rare (<1/10,000), frequency unknown (due to insufficient data).

From the hematopoietic system: very rarely - thrombocytopenia.

From the immune system: rarely - hypersensitivity reactions; very rarely - anaphylactic shock.

Mental disorders: infrequently - agitation; rarely - aggression, confusion, depression, hallucinations, sleep disturbance; very rarely - tic; frequency unknown - suicidal ideation.

From the nervous system: infrequently - paresthesia; rarely - convulsions; very rarely - taste perversion, dyskinesia, dystonia, fainting, tremor; frequency unknown - memory impairment, incl. amnesia.

From the organ of vision: very rarely - disturbance of accommodation, blurred vision, nystagmus.

On the part of the hearing organs: frequency unknown - vertigo.

From the cardiovascular system: rarely - tachycardia.

From the digestive system: infrequently - diarrhea; rarely - changes in liver function tests (increased activity of transaminases, alkaline phosphatase, GGT and bilirubin); frequency unknown - increased appetite.

From the skin and subcutaneous tissues: infrequently - skin rash, itching; rarely - urticaria; very rarely - angioedema, persistent drug erythema.

From the urinary system: very rarely - dysuria, enuresis; frequency unknown - urinary retention.

General disorders: infrequently - asthenia, malaise; rarely - peripheral edema, weight gain.

Adverse Reaction Alert

A system for reporting suspected adverse reactions after registration of a medicinal product is of great importance. This allows continuous monitoring of the benefit/risk ratio of the drug.

The clinical picture observed with an overdose of cetirizine was due to its effect on the central nervous system.

Symptoms: after a single dose of cetirizine at a dose of 50 mg, the following clinical picture was observed - confusion, dizziness, drowsiness, lethargy, stupor, weakness, anxiety, increased irritability, sedation, increased fatigue, malaise, headache, mydriasis, itching, tachycardia, tremor, urinary retention, dry mouth, diarrhea, constipation.

Treatment: immediately after taking the drug, it is necessary to perform gastric lavage or induce vomiting. It is recommended to prescribe activated carbon and carry out symptomatic and supportive therapy. A specific antidote is unknown. Hemodialysis is ineffective.

No clinically significant interactions of cetirizine with other drugs have been established.

Based on the results of drug interaction studies of cetirizine, in particular, interaction studies with pseudoephedrine or theophylline at a dose of 400 mg/day, no clinically significant interaction has been established.

The simultaneous use of cetirizine with ethanol and drugs that depress the central nervous system may further reduce concentration and reaction speed, although cetirizine does not enhance the effect of ethanol (at a blood concentration of 0.5 g/l).

Patients with impaired renal function, liver function and elderly patients should consult a doctor before taking the drug.

In patients with spinal cord injury, prostatic hyperplasia, as well as in the presence of other factors predisposing to urinary retention, caution is required, because Cetirizine may increase the risk of urinary retention.

It is recommended to be careful when using cetirizine concomitantly with alcohol, although at therapeutic doses no clinically significant interaction with ethanol was observed (at a blood ethanol concentration of 0.5 g/l).

Caution should be observed in patients with epilepsy and increased convulsive readiness.

Before prescribing allergy tests, a three-day “washing out” period is recommended due to the fact that histamine H1 receptor blockers inhibit the development of skin allergic reactions.

Use in pediatrics

Due to the potential depressant effect on the central nervous system, caution should be exercised when prescribing Zodak to children under 1 year of age who have the following risk factors for sudden infant death syndrome, such as (but not limited to):

- sleep apnea syndrome or sudden infant death syndrome in a brother or sister;

- maternal drug abuse or smoking during pregnancy;

- young age of mother (19 years and younger);

- smoking abuse by a nanny caring for a child (1 pack of cigarettes per day or more);

- children who regularly fall asleep face down and are not placed on their back;

- premature (gestational age less than 37 weeks) or low birth weight (below the 10th percentile of gestational age) children;

- when taking drugs together that have a depressing effect on the central nervous system. The drug contains excipients methylparabenzene and propylparabenzene, which can cause allergic reactions, incl. slow type.

Impact on the ability to drive vehicles and operate machinery

An objective assessment of the ability to drive vehicles and operate machinery did not reliably reveal any adverse events when using the drug Zodak in recommended doses. However, for patients with symptoms of drowsiness while taking the drug during the treatment period, it is advisable to refrain from driving a car, engaging in potentially hazardous activities, or operating machinery that requires increased concentration and speed of psychomotor reactions.

An analysis of prospective data from more than 700 cases of pregnancy outcomes revealed no cases of malformations, embryonic or neonatal toxicity with a clear cause-and-effect relationship.

Experimental studies in animals have not revealed any direct or indirect adverse effects of cetirizine on the developing fetus (including in the postnatal period), the course of pregnancy and postnatal development. Adequate and strictly controlled clinical studies on the safety of the drug during pregnancy have not been conducted, therefore Zodak should not be used during pregnancy.

Cetirizine is excreted in breast milk in amounts ranging from 25% to 90% of the drug concentration in the blood plasma, depending on the time after administration. During breastfeeding, it is used after consultation with a doctor, if the expected benefit to the mother outweighs the potential risk to the child.

Available data on the effects on human fertility are limited, but no adverse effects on fertility have been identified.

Tablets are contraindicated for use in children under 6 years of age.

The drug in the form of drops is contraindicated for use in children under 6 months of age (due to limited data on effectiveness and safety). Zodak drops should be prescribed with caution to children under 1 year of age.

Caution exercised when prescribing the drug in tablet form for chronic renal failure of moderate to severe severity (adjustment of the dosage regimen is required).

with caution in case of chronic renal failure (creatinine clearance >10 ml/min, dosage adjustment required).

The use of the drug is contraindicated in patients with end-stage renal failure (creatinine clearance <10 ml/min).

Caution exercised when prescribing the drug in tablet form for chronic liver diseases (hepatocellular, cholestatic or biliary cirrhosis) (dose adjustment is required only with a concomitant decrease in GFR).

The drug should be prescribed with caution to elderly patients.

The drug is available without a prescription.

Tablets should be stored at a temperature not exceeding 25°C; drops do not require special storage conditions. The drug should be stored out of the reach of children. Shelf life: 3 years. Do not use after the expiration date stated on the package.

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Source: http://health.mail.ru/drug/zodac_1/